PregnancyNCT06076941
Effect Of Oral And Dental Health Education In Pregnant Women
A study testing Education in people with Pregnancy, run by Tarsus University at 1 site in Turkey (Türkiye).
Trial summary
The study was conducted as a randomized controlled experimental study to determine the effect of the education given to pregnant women on their oral and dental health behaviors and knowledge levels. Read more about this study
- Who is it for?
- Ages 19 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Education
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2017to 14 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being in the first trimester of pregnancy
- Being 19-44 years old,
- Being able to read and write turkish,
- Being a healthy pregnant woman who agrees to participate in the study
Who cannot join
- Having a risky pregnancy,
- Can't speak or understand Turkish
- Women with intellectual disability
- Serious mental disorders will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Education on Oral and Dental Health Behaviors and Knowledge Levels of Pregnant Women
The study was conducted as a randomized controlled experimental study to determine the effect of the education given to pregnant women on their oral and dental health behaviors and knowledge levels.
Read the detailed description
In line with these results, it is recommended that midwives should determine the behaviors and knowledge levels of pregnant women regarding oral and dental health within the scope of primary health care services, provide trainings to increase their knowledge and awareness on the subject, refer them to treatment in the presence of problems, and expand these services within the health system.
- Conditions
- Pregnancy
- Being tested
- Education
- Keywords
- Prengnancy, oral and dental health, Education, knowledge and behavior
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
Before the training was given to the pregnant women in the experimental group who agreed to participate in the study, the Introductory Information Form, the Form for Assessing Pregnant Women's Behaviors Towards Oral and Dental Health, and the Form for Assessing Pregnant Women's Knowledge Levels Towards Oral and Dental Health were applied by face-to-face interview method. The application of the forms took 20-30 minutes. Then, a training time was planned on a suitable date for the pregnant women.
In order to ensure the effectiveness of the training, to answer the questions of the pregnant women effectively and to be able to direct them to the dentist in line with their needs, the training was applied in groups of maximum five people. Lecture, question and answer and demonstration methods were used in the training.
One month after the training, the necessary forms were applied to the pregnant women and the study was terminated.
| Study group | Role | What they receive |
|---|---|---|
| Education | Experimental | Pregnant women in the experimental group were given oral and dental health education in groups of maximum five, and the forms were filled out before and one month after the education. Receives: Other: Education |
| Control | No intervention | No intervention was made to the pregnant women in the control group, and the forms were completed before and one month after the training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Form for Assessment of Knowledge Levels of Pregnant Women Regarding Oral and Dental Health
This form was developed by the researcher by reviewing the literature to determine the knowledge levels of pregnant women about oral and dental health and their educational needs in this direction. The form includes 22 questions assessing the importance of dietary habits for oral and dental health, visiting a dentist during pregnancy, dental and gum treatment during pregnancy, and dental x-rays during pregnancy. The form is evaluated by giving "1 point" for correct answers and "0 point" for incorrect answers in line with the answer key specified in Appendix 4. The lowest score that can be obtained from the form is 0 and the highest score is 22. High scores indicate a high level of knowledge.
Measured: up to 24 weeks
Form for Assessment of Oral and Dental Health Behaviors of Pregnant Women
This form was developed by the researcher by reviewing the literature to determine the oral and dental health behaviors of pregnant women. The form consists of 16 questions evaluating the behaviors of pregnant women such as current dental health status, frequency of tooth brushing, tooth brushing technique, fluoride toothpaste use, frequency of flossing and frequency of toothbrush replacement.
Measured: up to 24 weeks
Pregnant Women's Education Satisfaction Evaluation Form
This form was prepared by the researcher to evaluate the effectiveness and benefits of the training and the opinions of the pregnant women in the experimental group after the training.
Measured: up to 24 weeks
Descriptive Information Form
This form was developed by the researcher and consisted of two parts: sociodemographic characteristics and obstetric characteristics of pregnant women. Sociodemographic characteristics included questions such as age, education level, employment status, spouse's employment status, income level and family type. Obstetric characteristics included information on the number of pregnancies, number of living children and gestational week. There are 14 questions in the descriptive information form
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start15 Apr 2017
- Primary completion15 Apr 2017
- Study completion14 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was conducted as a randomized controlled experimental study to determine the effect of the education given to pregnant women on their oral and dental health behaviors and knowledge levels. With the power analysis, α = 0.05, β = 0.20, 1-β = 0.80, a total of 60 pregnant women, 30 in the experimental group and 30 in the control group were included (the power of the test was found as p = 0.8056).
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarsus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Guray, Tarsus University
- Investigators
- Özlem DURAN AKSOY, Study director, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076941
- Sponsor's protocol ID
- TarsusU2
- Status last verified
- Oct 2023
- First submitted
- 24 Sep 2023
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Education on Oral and Dental Health Behaviors and Knowledge Levels of Pregnant Women
- ClinicalTrials.gov ID
- NCT06076941
- Acronym / sponsor ID
- TarsusU2
- Conditions
- Pregnancy
- Keywords
- Prengnancy, oral and dental health, Education, knowledge and behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tarsus UniversityUniversity, hospital or other
- Study start
- 15 Apr 2017 (actual)
- Primary completion
- 15 Apr 2017 (actual)
- Study completion
- 14 Oct 2020 (actual)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study was conducted as a randomized controlled experimental study to determine the effect of the education given to pregnant women on their oral and dental health behaviors and knowledge levels.
Detailed description
In line with these results, it is recommended that midwives should determine the behaviors and knowledge levels of pregnant women regarding oral and dental health within the scope of primary health care services, provide trainings to increase their knowledge and awareness on the subject, refer them to treatment in the presence of problems, and expand these services within the health system.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study was conducted as a randomized controlled experimental study to determine the effect of the education given to pregnant women on their oral and dental health behaviors and knowledge levels. With the power analysis, α = 0.05, β = 0.20, 1-β = 0.80, a total of 60 pregnant women, 30 in the experimental group and 30 in the control group were included (the power of the test was found as p = 0.8056).
| Arm | Type | Receives |
|---|---|---|
| Education | Experimental | Other: EducationPregnant women in the experimental group were given oral and dental health education in groups of maximum five, and the forms were filled out before and one month after the education. |
| Control | No intervention | –No intervention was made to the pregnant women in the control group, and the forms were completed before and one month after the training. |
Who may qualify
- Ages
- 19 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Being in the first trimester of pregnancy
- Being 19-44 years old,
- Being able to read and write turkish,
- Being a healthy pregnant woman who agrees to participate in the study
Key exclusion criteria (4 listed)
- Having a risky pregnancy,
- Can't speak or understand Turkish
- Women with intellectual disability
- Serious mental disorders will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationBefore the training was given to the pregnant women in the experimental group who agreed to participate in the study, the Introductory Information Form, the Form for Assessing Pregnant Women's Behaviors Towards Oral and Dental Health, and the Form for Assessing Pregnant Women's Knowledge Levels Towards Oral and Dental Health were applied by face-to-face interview method. The application of the forms took 20-30 minutes. Then, a training time was planned on a suitable date for the pregnant women. In order to ensure the effectiveness of the training, to answer the questions of the pregnant women effectively and to be able to direct them to the dentist in line with their needs, the training was applied in groups of maximum five people. Lecture, question and answer and demonstration methods were used in the training. One month after the training, the necessary forms were applied to the pregnant women and the study was terminated. | Other | Education |
Primary outcome
Form for Assessment of Knowledge Levels of Pregnant Women Regarding Oral and Dental Health
Time frame: up to 24 weeks
This form was developed by the researcher by reviewing the literature to determine the knowledge levels of pregnant women about oral and dental health and their educational needs in this direction. The form includes 22 questions assessing the importance of dietary habits for oral and dental health, visiting a dentist during pregnancy, dental and gum treatment during pregnancy, and dental x-rays during pregnancy. The form is evaluated by giving "1 point" for correct answers and "0 point" for incorrect answers in line with the answer key specified in Appendix 4. The lowest score that can be obtained from the form is 0 and the highest score is 22. High scores indicate a high level of knowledge.
Form for Assessment of Oral and Dental Health Behaviors of Pregnant Women
Time frame: up to 24 weeks
This form was developed by the researcher by reviewing the literature to determine the oral and dental health behaviors of pregnant women. The form consists of 16 questions evaluating the behaviors of pregnant women such as current dental health status, frequency of tooth brushing, tooth brushing technique, fluoride toothpaste use, frequency of flossing and frequency of toothbrush replacement.
Pregnant Women's Education Satisfaction Evaluation Form
Time frame: up to 24 weeks
This form was prepared by the researcher to evaluate the effectiveness and benefits of the training and the opinions of the pregnant women in the experimental group after the training.
Descriptive Information Form
Time frame: up to 24 weeks
This form was developed by the researcher and consisted of two parts: sociodemographic characteristics and obstetric characteristics of pregnant women. Sociodemographic characteristics included questions such as age, education level, employment status, spouse's employment status, income level and family type. Obstetric characteristics included information on the number of pregnancies, number of living children and gestational week. There are 14 questions in the descriptive information form
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Özlem DURAN AKSOY study director
Cumhuriyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Pregnancy, run by Tarsus University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Form for Assessment of Knowledge Levels of Pregnant Women Regarding Oral and Dental Health (time frame: up to 24 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023.